Retractor/compression/distraction system

ABSTRACT

A minimally invasive system for retraction, compression and distraction includes a tap having a shaft with threads and a head, a blade having a proximal end and a distal end and a base removably mountable to the proximal end. The tap is configured to form screw threads in a bone. The distal end is mountable to the head. The blade is pivotable relative to the head in a mounted configuration. The blade is configured to facilitate soft tissue retraction in the mounted configuration. The base is configured to manipulate the blade to retract and compress segments of the bone. The base is configured to provide distraction and/or compression using the provisional taps either directly or through the use of blades, insertion devices or tubes. The blades may be used to retract tissue and provide a visual field either independent or in conjunction with the provisional taps, insertion devices or tubes.

This application is a continuation of U.S. patent application Ser. No.15/833,737, filed Dec. 6, 2017 and entitled“Retractor/Compression/Distraction System”, which claims priority toU.S. Provisional Patent Application No. 62/430,465 filed on Dec. 6, 2015and entitled “Retractor/Compression/Distraction System”. The content ofeach of the above applications is hereby incorporated by reference.

BACKGROUND OF THE INVENTION

Retractor systems for minimally invasive (“MIS”) surgery are designed toretract off of permanent screws placed in bone or with free standingsystems (“FSS”) that are independent of any implanted device which areattached to the bones. These retraction systems may be free standing oroften require attachment to a stable structure, such as the surgicaltable via arm-like attachments. Similarly, compression/distraction ofspine segments is typically accomplished via permanently placedscrews/pins/nails/hooks that are left implanted in the patient.

There is no readily known retractor system design available that isuniversal for nearly any cannulated screw system that provides thetechnical advantage of applying retraction/compression/distraction byconnecting to a temporary/provisionally inserted device attached to thebone, such as a tap. All current non-FSS systems typically require theplacement of permanent screws in order to distract/compress/retract.This limitation of retractor availability and function has resulted inmany companies being unable to compete in the market of minimallyinvasive spine surgery, because each screw system is typically tied to aspecific retractor, distractor, compression instrument and technique.Systems may also utilize disposable pins to mount to bones forcompression, but such systems require disposal of the relativelyexpensive pins following use, which is a generally inefficient use ofthe pins.

The preferred present invention addresses the deficiencies of the knownprior art systems and methods, permitting use of nearly any cannulatedpedicle screw with the system.

BRIEF SUMMARY OF THE INVENTION

Briefly stated, the preferred invention is directed to a minimallyinvasive system for retraction, compression and distraction during asurgical procedure. The preferred system is not limited to MISprocedures and may be utilized with generally open or partially openprocedures and for numerous surgical procedures, but, most preferably,for spinal procedures. Procedures that may benefit from the use of thepreferred system include, but are not limited to, anterior, posteriorand lateral cervical decompression and fusion procedures, generalcervical procedures, thoracic procedures, lumbar procedures, sacrum andpelvis procedures, skull procedures and numerous additional procedureswhere distraction, compression and/or retraction is desirable. Thesystem includes a tap having a shaft with threads and a head, a bladehaving a proximal end and a distal end and a base removably mountable tothe proximal end. The tap is configured to form screw threads in a boneand for removal from the bone before the completion of the surgicalprocedure. The distal end is mountable to the head. The blade ispivotable relative to the head in a mounted configuration. The blade isconfigured to facilitate soft tissue retraction in the mountedconfiguration to create a surgical path to a surgical site. The base isconfigured to manipulate the blade to retract and compress segments ofthe bone during the surgical procedure. The blade may be configured topivot or hinge from its proximal end to assist with retraction of softtissue and create a wider field of vision at the surgical site. Theblade may also be configured to pivot or hinge from alternative ormultiple positions, such as near a middle portion of the blade orproximate a distal end of the blade. The blade is also preferablyselectively lockable in numerous positions to maintain a preferredsurgical path.

The preferred minimally invasive retractor uniquely allowsretraction/compression/distraction via provisionally placed implantswhich are eventually removed and allows placement of already existingscrew systems. Because of its design it allows for optimal visualizationand working space to perform a desired surgical procedure. In anotherembodiment the preferred retractor system may be used without theeventual placement of permanent screws that replace the provisional tap.In another embodiment the preferred retractor system and the preferredtaps can be used for parts of the procedure and substituted atappropriate times during the procedure for another existing system.

The preferred system is utilized for MIS or opendecompressions/fusions/spine surgery that compress/distract/retract offof a provisional tap that is used to create threads in a hole drilled ina bone. This tap may be used to create a path for cannulated or solidscrews such that the threads of the non-tapping screws follow thepre-formed threads in the bone from the tap. This system can be used fornearly any screw based system in the spine, such as for a cannulatedpedicle screw or a solid screw that is driven into a pre-formed andthreaded hole formed by taps.

The preferred system utilizes a non-screw or non-permanent implant,provisionally placed component, such as a pin, screw, tap, threadedcomponent, solid component or other implement or instrument whosepurpose is to be provisional and may be replaced by a final implant suchas a screw.

The preferred retractor system allows competition among orthopaedic andspinal implant companies by permitting use of nearly any screw with thepreferred system, thereby bringing down the cost of spine surgery. Theneed to spend money and resources on additional research and developmentwill be limited or avoided, as pre-existing screw systems will be ableto be used either for the first time and/or more effectively with thepreferred universal minimally invasive retractor/compression/distractionsystem.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

The foregoing summary, as well as the following detailed description ofpreferred embodiments of the instrument, implant and method of thepresent application, will be better understood when read in conjunctionwith the appended drawings. For the purposes of illustrating theuniversal minimally invasive retractor/compression/distraction system,there are shown in the drawings preferred embodiments. It should beunderstood, however, that the application is not limited to the precisearrangements and instrumentalities shown. In the drawings:

FIG. 1 is right side elevational and top plan views of a prior artjamshidi needle insertion step utilized in the process related to apreferred embodiment of the present invention;

FIG. 2 is right side elevational and top plan views of a prior art guidewire insertion step utilized in the process related to the preferredembodiment of the present invention;

FIG. 3 is a right side elevational view of a prior art jamshidi needleremoval in accordance with the process related to the preferredembodiment of the present invention;

FIG. 4 is right side elevational and top plan views of taps anddistractor/retractor blades in accordance with the preferred embodimentof the present invention inserted into a spinal segment;

FIG. 5 is a right side elevational view of the taps anddistractor/retractor blades of FIG. 4 with the guide wires removed;

FIG. 6 is right side elevational and rear elevational views of the tapsand distractor/retractor blades of FIG. 4 with a retractor/distractorbody connected thereto in accordance with the preferred embodiment ofthe present invention;

FIG. 7 is right side elevational and rear elevational views of theassembly of FIG. 6, wherein the spinal segment is distracted;

FIG. 8 is a right side elevational view of the assembly of FIG. 6,wherein disc material is being removed and an interbody device isinserted in the disc space;

FIG. 9 is a right side elevational view of the assembly of FIG. 6,wherein the spinal segment is compressed;

FIG. 10 is a right side elevational view of the taps anddistractor/retractor blades of FIG. 4, wherein the retractor/distractorbody is removed and guide wires are inserted;

FIG. 11 is a right side elevational view of the taps anddistractor/retractor blades of FIG. 4, wherein tap handles are insertedto remove the taps and distractor/retractor blades;

FIG. 12 is a right side elevational view of the spinal segment with theguide wires inserted therein and the taps and distractor/retractorblades of FIG. 4 removed;

FIG. 13 is a right side elevational view of cannulated screws insertedinto the vertebrae of the spinal segment;

FIG. 14 is a right side elevational and rear elevational views of a rodsecured to the cannulated screws that are secured to the spinal segment;and

FIG. 15 is a series of side perspective views of various instruments,implants and components utilized in the procedure related to thepreferred process of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

Certain terminology is used in the following description for convenienceonly and is not limiting. Unless specifically set forth herein, theterms “a”, “an” and “the” are not limited to one element but insteadshould be read as meaning “at least one”. The words “right”, “left”,“lower” and “upper” designate directions in the drawings to whichreference is made. The words “inwardly” or “distally” and “outwardly” or“proximally” refer to directions toward and away from, respectively, thepatient's body, or the geometric center of the preferred universalminimally invasive retractor/compression/distraction system and relatedparts thereof. The words, “anterior”, “posterior”, “superior,”“inferior”, “lateral” and related words and/or phrases designatepreferred positions, directions and/or orientations in the human body towhich reference is made and are not meant to be limiting. Theterminology includes the above-listed words, derivatives thereof andwords of similar import.

It should also be understood that the terms “about,” “approximately,”“generally,” “substantially” and like terms, used herein when referringto a dimension or characteristic of a component of the preferredinvention, indicate that the described dimension/characteristic is not astrict boundary or parameter and does not exclude minor variationstherefrom that are functionally the same or similar, as would beunderstood by one having ordinary skill in the art. At a minimum, suchreferences that include a numerical parameter would include variationsthat, using mathematical and industrial principles accepted in the art(e.g., rounding, measurement or other systematic errors, manufacturingtolerances, etc.), would not vary the least significant digit.

Referring to FIGS. 1-15, the preferred invention is directed to aretractor/compression/distraction system, generally designated 10, thatpermits retraction, distraction and compression of bone segments duringa surgical procedure, preferably during a surgical procedure related toa spine segment. The preferred retractor/compression/distraction system10 is directed to a universal minimally invasiveretractor/compression/distraction system 10, but is not so limited andthe system 10 may be utilized in open, partially open and other relatedprocedures. The universal minimally invasiveretractor/compression/distraction system 10 of the preferred embodimentincludes taps 12, blades 14 that are removably mountable to the taps 12and a base 16 that is removably mountable to the blades 14.

In the preferred embodiment, the taps 12 each include a head 12 a and ashaft with threads 12 b thereon. The tap 12 is configured to form screwthreads in a bone, such as a superior vertebra V_(S) or an inferiorvertebra V_(I), during the surgical procedure. The tap 12 is not limitedto forming threads in the bone and may be configured to form a pilothole in the bone for introduction of a implant into the pilot hold foruse during later portions of the surgical procedure. The tap 12 is alsoconfigured for removal from the bone V_(S), V_(I) before completion ofthe surgical procedure, generally meaning that the tap 12 is not animplant that remains in the patient's body following the surgery, but isinserted and removed during the surgical procedure. In the preferredembodiment, the tap 12 includes a first tap 12 and a second tap 12 thatare mountable to different bones, such as the superior and inferiorvertebrae V_(S), V_(I), or may be removably mountable to the same boneduring the procedure.

The preferred taps 12 are preferably comprised of cannulated taps 12that create threads with the tap threads 12 b in a bone after a pilothole is drilled into the bone. The taps 12 preferably create threads incortical bone that is encountered by the taps 12. The taps 12 may alsobe self-tapping for forming the threads. The taps 12 preferably includethe head 12 a that is adaptable and configured to receive a distal end14 c of the blades 14, such that the blades 14 are pivotable relative tothe heads 12 a of the taps 12 in the mounted configuration and may belocked to the taps 12 for distraction and compression, as will bedescribed in greater detail below. The taps 12 may be placed with aninsertion device or tubes (not shown), each of which may assist with thefunction provided by the taps 12. The taps 12 are not limited to thetaps 12 specifically shown in the attached drawings and may be comprisedof nearly any provisional non-permanent device that may providedistraction/retraction/compression support, may mark a surgical locationfor eventual placement of permanent implants, such as a screws, may bethreaded or non-threaded, may be cannulated or non-cannulated, may becomprised of a nail/pin/marker, may provide for electrical monitoring ofnerves, may attach to the retractor blades 14, may connect to theretractor blades 14 as a single unit or may be connected to the blades14 before, after or during insertion, may vary in height relative to thebone, i.e above or below the bone or above the skin for different designpurposes and may be placed over a guide wire 20 or without a wire. Thesystem 10 may be utilized in spine surgery with our without the guidewire 20, without significantly impacting the design or operation of thesystem 10 or the procedure. The taps 12 may be used with or withouttubes or sleeves for insertion purposes that may assist in the functionof the taps 12. The taps 12 may be disposable or re-usable, may beradioluscent or opaque and may connect directly to the base 16 orconnect via an intervening device, such as the blades 14, to the base16. The taps 12 preferably allow for distraction or compression whetherdirectly or via an intervening device.

In the preferred embodiment, the taps 12 may be comprised of anyprovisionally placed device inserted into the bone, preferably a pedicleof vertebral body, or other boney region in the spine or elsewhere inbody to allow attachment to a device fordistraction/retraction/compression. The taps 12 are preferably removedfollowing distraction/retraction/compression for possible placement of afinal implant such as a screw and, more preferably, a pedicle screw 18.The taps 12 are preferably used during the surgical procedure, but arealso, preferably not permanently implanted in the patient post-op. Thepreferred taps 12 include the threads 12 b, but may also benon-threaded. The taps 12 are most preferably threaded to form threadsin the bone, as is described herein. The location of the taps 12preferably become the site of a final implant, such as the pediclescrews 18 that are implanted into the holes with the screw threadscreated by threads 12 b of the taps 12. The taps 12 are not limited tocreating the screw threads in the bone and may be relatively smooth, butstill form holes for subsequent insertion of a final implant, such asthe pedicle screws 18. In the preferred embodiment, the taps 12 arecannulated such that they may be guided to their insertion position by aguide wire 20 and may be able to be placed over a guide wire 20, but arenot so limited and the taps 12 may be guided or placed through a tube orsleeve (not shown), implanted with assistance from an inserter (notshown) or generally freehand by a surgeon without a tube or sleeve. Thepreferred taps 12 are removably connected at their proximal ends toblades 14. The blades 14 are preferably configured for retraction,compression, compaction and distraction. The taps 12 of the preferredembodiment are cannulated and threaded, but are not so limited and maybe cannulated and not threaded, non-cannulated and threaded ornon-cannulated and non-threaded, depending on the technique being used,the surgery being performed, designer preferences and numerous otherfactors.

The universal minimally invasive retractor/compression/distractionsystem 10 of the preferred embodiment does notconnect/interdigitate/rely upon connecting to an implanted boney device,such as a screw, hook, pin, nail or other implanted device that remainsin the patient following the surgery. The system 10 preferably utilizesa temporarily secured component, such as the taps 12, to engage the boneand provide a relatively stiff and strong component for attachment ofretractor blades and/or compression/distraction components to-retractsoft tissue, distract bone segments, compress bone segments or otherwisemanipulate soft tissue and bone segments, such as a spinal segment,during a surgical procedure.

The blades 14 of the preferred embodiment include a proximal end 14 band a distal end 14 c. In use, the distal ends 14 b are preferablyselectively positionable in the patient near the surgical site and theproximal ends 14 a are positioned outside of the patient for graspingand manipulation during the procedure. In the preferred procedure, thedistal end is mountable to the head 12 a of the tap 12

The system 10 preferably does not include an implanted screw, such asthe pedicle screws 18, that are final implants left in the patient attime of closure. The system 10 preferably does include the taps 12,which may be threaded with the threads 12 b, non-threaded, solid,cannulated, hooked or any other device that connects to bone, but ispreferably not retained within the patient following the surgicalprocedure.

As described herein, the distraction process relates to separationacross bone segments, generally a spinal segment including a superiorvertebra V_(S) and an inferior vertebra V_(I), whether it bedistraction, rotation, flexion, extension or other related movement.

As described herein, the compression process relates to closing ordecreasing space across a bone segment, generally a spinal segmentincluding the superior and inferior vertebrae V_(S), V_(I), whether itbe compression, rotation, flexion, extension or other related movement.

As described herein, retraction relates to an activity that moves tissueout of the way to provide better visualization and access, preferablysoft tissue during a surgical procedure. In the preferred embodiment,the blades 14 are configures to facilitate soft tissue retraction in themounted configuration to create a surgical pathway or path to thesurgical site. The blades 14 are preferably secured to the heads 12 a ofthe taps 12 in the mounted configuration and the blades 14 retract orurge soft tissue away from and out of the surgical path during use.

As described herein, retractor blades or blades 14 are preferablycomprised of devices or instruments that assist in providing at leastretraction and, also, preferably, distraction and compression with thepreferred system 10.

As described herein, the base or frame 16 is a device that releasablyconnects to blades 14, independently, together or in variouscombinations. The base 16 preferably permits manipulation of the blades14 for retraction of soft tissue, compression of the bone segments anddistraction of the bone segments. The base 16 is preferably connected ator near the proximal ends 14 b of the blades 14 during use. The base 16is specifically removably mountable to the proximal ends 14 b ofadjacent blades 14 during the preferred procedure. The base 16 isconfigured to manipulate the blades 14 to retract and compress segmentsof the bone, such as the superior and inferior vertebrae VS, VI, duringthe preferred surgical procedure. The base 16 preferably includes agearing system 28 that provides a mechanical advantage to the user whenretracting and distracting via the blades 14.

The preferred universal minimally invasiveretractor/compression/distraction system 10 is preferably configured formultilevel options that allow staggering of screws 18 and taps 12. Thesystem 10 may be utilized for multilevel procedures, preferably formultilevel spine procedures.

The preferred blades 14 can be rotated to accommodate a second level orfurther multiple level procedures. In addition, the system 10 mayinclude a lateral or middle level blade (not shown) that can be rotatedand move transverse relative to the base 16 to facilitate retractionlaterally and/or medially to expand the surgical path.

The system 10 may be utilized for adjacent level, second level surgeryby placing the guide wire 20 through cannulated screw 18 and removingscrew 18 with subsequent placement of the taps 12 into the holes vacatedby the screws 18. The taps 12 may be selected to have a larger diameterin comparison to the screws 18 that are removed from the patient topermit cutting of new screw threads in the bone, preferably along thepedicles of the superior and inferior vertebrae V_(S), V_(I). Theexisting screws 18 may alternatively be preserved in the patient and aconnection device may engage the previously inserted screws 18 withscrews 18 that are implanted at adjacent or second level surgical sites.

The preferred blades 14 of the system 10 may have multiple lengths toaccommodate various patient anatomy, may have the ability to angleout/in (fixed or adjustable) (static angle or dynamic angle), may havethe ability to rotate relative to the base 16 or along their length, maybe comprised of a disposable material, may provide retractor benefits,may provide distraction/compression benefits, may connect to the taps 12via eyelets 14 a, hooks or fasteners, may connect via post to the insideof cannulated taps 12, may be inserted as one unit with the taps 12, arepreferably placed/connected to the taps 12 after the taps 12 areinserted, may be inserted as a combined unit with the taps 12 as amodular or single unit, may be able to rotate around the tap 12 to whichit is attached, is preferably connected to the base 16 in a mountedconfiguration, may act as a fiduciary for image guided systems, arepreferably strong enough to sustain forces applied to the blades 14during normal operation, may be translucent or opaque, may have hingesat single or multiple sites and may connect directly to the base 16 oronly to the taps 12 or other independent second base or supportstructures.

The preferred base 16 of the system 10 connects to the blades 14,preferably at or near the proximal ends 14 b, may connect to the taps12, is preferably configured to allow the blades 14 to angle outstatically or dynamically, may be configured to allow the blades 14 todistract a motion segment or bone segments, may allow the taps 12 toangle out statically or dynamically, may connect to other retractorblades 14 in any position within or outside the base 16, may beconfigured for connection to additional retractor blades 14 that attachto the base 16 independent of the taps 12, may allow the retractorblades 14 and the taps 12 to work independently wherein the retractorblades 14 provide retraction and the taps 12 provide distraction and/orcompression, may be connected to a stationary or structural supportobject (not shown) for additional support or may act as a fiduciary forimage guided systems (not shown). The base 16 of the preferred system 10may include arms (not shown) that extend over the taps 12 and functionas retractor blades, may allow the taps 12 and blades 14 to connectindependently where each has independent connection and may allowconnections to the blades 14 for medial and lateral or other geometricretraction of soft tissue.

In operation, the system 10 is preferably utilized for spinal surgeries,but is not so limited and may be utilized for any procedure related tobones or joints. In a preferred procedure, the system 10 is utilized ina spinal procedure to manipulate a spinal joint, which includes asuperior vertebra V_(S) and an inferior vertebra V_(I). A preferredspinal procedure utilizing the system 10 may be performed with a spinalneedle, such as an 18 gauge spinal needle, a scalpel, a jamshidi needle22, the guide wire 20, a tissue clearer or spreader, the taps 12, theblades 14, the base 16, a screw driver 24, a tap handle 26 and thescrews 18. In an example preferred procedure, the jamshidi needle 22 isused to target a portion of the surgical site associated with thesurgical procedure, such as the pedicles of the superior and inferiorvertebrae V_(S), V_(I), a pilot hole may be drilled into the bone, theguide wires 20 are inserted into the pedicles of the superior andinferior vertebrae V_(S), V_(I), the jamshidi needle 22 is removed fromthe guide wires 20, the tissue clearer/spreader is moved over the guidewires 20, the depth of the guide wires 20 is measured for tap height andeventual screw length, the depth of the facet-skin surface is measuredfor retractor blade length, the tissue clearer/spreader is removed fromthe guide wires 20, the taps 12 are inserted over the guide wires 20 forguiding the taps 12 to the surgical site and driven into the pedicles,the retractor blades 14 are attached to the taps 12, the blades 14 areangled and rotated to provide soft tissue retraction, the base 16 isconnected to the blades 14, the superior and inferior vertebrae V_(S),V_(I) are distracted and/or compressed across the taps 12 that willultimately be removed from the patient during the procedure, conduct theprocedure, the guide wire 20 is moved through the cannulated taps 12,the base 16 is removed from the blades 14, the taps 12 are removed fromthe superior and inferior vertebrae V_(S), V_(I), the pedicle screws 18are driven into the pedicles along the screw threads created by the taps12, nearly any screw 18 can be used from nearly any manufacturer at thispoint in the procedure for insertion into the pedicle, the guide wires20 are removed, the rods and caps are added to the screws 18 and theprocedure is completed.

In an alternative preferred procedure, the system 10 may be utilized togain percutaneous access to a pedicle and threading of the pedicle withthe taps 12 for decompression of the spine segment including thesuperior and inferior vertebrae V_(S), V_(I), removal of disc materialin the spine segment, insertion of a interbody device and placement ofthe screws 18, rods and caps. In this preferred procedure, the jamshidineedles 22 are placed, the guide wires 20 are inserted through theplaced jamshidi needles 22, the jamshidi needles 22 are removed from thepedicles over the guide wires 20 and the taps 12 are placed via thecannulated tap handle 26 over guide wire 20 into the bone. The taphandle 26 is preferably used to urge the tap 12 into the bone. Theblades 14 are attached to the taps 12 prior to or following driving thetaps 12 into the bone. The blades 14 are preferably attached to the taps12 such that they are pivotable to assist with retraction of soft tissue(FIGS. 4 and 5). In the preferred embodiment, the blades 14 areremovably connected to the taps 12 by an eyelet 14 a at the distal end14 c of the blades 14. The eyelet 14 a extends over the shaft of thetaps 12 and is positioned under a head 12 a of the taps 12 in a workingconfiguration to mount the distal end 14 c of the blades 14 to the heads12 a of the taps 12, respectively. The blades 14 are not limited toincluding the eyelets 14 a for connection to the taps 12 and may includenearly any connection mechanism that permits connection to the taps 12and is able to perform the preferred functions of the connection betweenthe blades 14 and taps 12. The eyelets 14 a are not limited to bepositioned at the distal ends 14 c of the blades 14 and may be somewhatspaced from the distal ends 14 c, while permitting connection ormounting of the blades 14 to the heads 12 a, respectively. Theconnection options may allow independent placement of the blade 14 toattach to the taps 12 after the taps 12 are inserted into the bones. Thetaps 12 and blades 14 may also be inserted to the surgical site throughtubes (not shown) to assist placement. The blades 14 may be attached totaps 12 while the taps 12 are inserted into the pedicles of the superiorand inferior superior and inferior vertebrae V_(S), V_(I). Followinginsertion of the taps 12 and potentially the blades 14, the guide wires20 and/or any additional insertion instruments are removed from thesurgical path. Following removal of the guide wires 20, the preferredblades 14, with their hinged and pivoting ability, are able to aid withretraction of soft tissue while attached to the taps 12 to increasevisualization of the surgical site.

Following removal of the guide wires 20, the base 16 is preferablyattached directly to blades 14 at or near the proximal ends 14 b of theblades 14. The blades 14 may also be hinged at various angles relativeto the base 16 to customize the surgical path and retraction of softtissue, but are preferably in a substantially perpendicular orientationrelative to the blades 14, as is shown in FIGS. 6-9. In this preferredexample procedure, once the blades 14 are attached to the base 16, theblades 14 can be distracted away from each other to provide distractionof the spinal segment, thereby moving the superior vertebra V_(S) awayfrom the inferior vertebra V_(I). The distraction occurs as the bladesmove apart as they are attached to the taps 12 causing the bones to moveaway from each other. Similarly, if and when desired, compression can beapplied by urging the blades 14 and taps 12 toward each other using thebase 16, which preferably includes a mechanical advantage mechanism 28,such as a gearing system 28 to move the blades 14 relative to eachother. In this preferred embodiment the mechanical advantage mechanism28 of the base 16 is comprised of a ratcheted system 28 witharticulating/hinged parts that allow bending of the system 10 out of theway of the surgical field and the surgical path.

Referring to FIG. 7, the base 16, blades 14 and taps 14 are utilized todistract the interbody disc space or motion segment. The disc in thesegment is shown as floating freely in the lower schematic in thissegment for illustration purposes only, as the disc would typicallyremain attached to the superior and inferior vertebrae V_(S), V_(I)during distraction, often from an overly compressed configuration priorto the surgical procedure.

The preferred system 10 is configured for potential distraction,retraction and/or compression across segmental motion segments orbetween segments of bone. The taps 14 are preferably mounted to the bonefor distraction, retraction and/or compression of the motion segment orthe bone segments, removal from the bone and for potential placement ofpermanent devices during the procedure.

Referring to FIG. 8, the disc material is then preferably removed orextracted and an interbody implant 30 is chosen and placed between thesuperior and inferior vertebrae V_(S), V_(I) by the surgeon. Portions ofthe superior and inferior vertebrae V_(S), V_(I) may also be removed toclear additional space from the spinal segment to create some blood flowand increase the usable space. Placement of the interbody implant 30 isnot limiting and the surgeon may conduct alternate procedures notinvolving the interbody implant 30. The surgeon may perform othersurgical procedures at this step including bone resection, such as alaminectomy, a laminotomy or other related procedures.

Referring to FIG. 9, the system 10 may also be utilized to providecompression at this stage of the procedure, if desired. The gearing orratcheting system 28 drives the blades 14 and taps 12 toward each otherto create compression between the superior and inferior vertebrae V_(S),V_(I) and the interbody spacer 30. Alternatively, the taps 12 and blades14 may be comprised of a single unit and have features that permitrotation, pivoting, flexing and extending to facilitate retraction ofsoft tissue. Further, insertion devices (not shown) for the taps 12 orblades 14 may be utilized to retract/distract/compress. The insertiondevices may be placed through tubes that may also assist withretraction, distraction and/or compression.

Referring to FIG. 10, the base 16 is removed from the blades 14 and theguide wires 20 are re-inserted directly into the cannulations in thetaps 12. In this preferred embodiment, tubes are not used to place theguide wires 20 as they are placed with direct visualization. In thispreferred embodiment the base 16 is removed after the guide wires 20 areplaced, but the procedure is not so limited. The procedure mayalternatively be performed using inserters with the guide wires 20 beingplaced through the insertion devices. In a further alternativeprocedure, the taps 12 may be solid without cannulation, such that guidewires 20 are not required for the procedure.

Referring to FIG. 11, the tap handle 26 is moved over the guide wire 20to reattach to the taps 12. The cannulated tap handle 26 preferably doesnot attach to the blades 14. In other preferred embodiments, guide tubesmay be used to guide the tap handle 26. In other embodiments, the blades14 may be used to place tubes and help guide the guide wire 20 back intothe taps 12.

Referring to FIG. 12, the taps 12, blades 14 and tap handle 26 areremoved from the surgical site. The guide wires 20 are preferablyretained in the pre-formed holes with screw threads in the bones. Atthis point, surgical options may include placement of pedicle screws 18of surgeon's choice, including solid, cannulated, hooks, rods or otherimplants. The screws 18 or other implants may even be selected at thisstage of the procedure to optimize the advantages of various systems.Alternatively, the surgeon may or may not choose to place any permanentimplants into or near the bones at this stage of the procedure.

Referring to FIG. 13, the guide wires 20 that are left behind from arepreferably being used for placement of cannulated permanent screws 18with use of the cannulated screw driver 24. These screws 18 can be fromany number of existing spine systems, as the preferred system 10 is notlimited to being used with any particular screw system. In addition, theinsertion of permanent implants is not required and a surgeon mayperform a procedure with the preferred system 10 without insertingpermanent implants.

Referring to FIG. 14, the screw 18 preferably includes a threaded distalportion 18 b and a tulip head 18 a at a proximal portion. The screw 18is configured to engage the screw threads formed in the bone by the taps12 after the tap 12 is removed from the bone. For example, the taps 12may form threads in the pedicle area of the superior or inferiorvertebra V_(S), V_(I) and the threaded distal portion 18 b is configuredto engage the threads in the pedicle portion after the tap 12 is removedfrom the bone. The tulip head 18 a is preferably configured to acceptplacement of rods 32, which can be accomplished in multiple fashionsusing screw and rod systems.

Referring to FIGS. 1-15, the preferred system 10 may be utilized forvarious procedures and in various areas of the body, including in thelumbar spine, in the sacrum, in the pelvis, in the thoracic spine, inthe cervical spine, with the skull, for spanning and connecting as isshown in FIGS. 1-6, in other boney non-spine procedures, in repeat spinesurgeries involving same level repeat surgery, adjacent levels to beconnected to previous surgery, as well as non-contiguous levels, withadditional retractor blade optional attachments to the base 16 toprovide medial and lateral benefits and in other related procedures andprocesses.

In the application of spine surgery, the preferred system 10 provides auniversal system that allows better visualization of a surgical fieldthan if permanent bulky screws were placed as the anchoring point for aretractor system. Alternatively, FSS are also available requiringanchoring to other fixed devices. In the application of spine surgerythis device may provide a distinctly different technique with regards tothe order of surgical events for spine surgery that does not requireengaging the distraction or compression systems to permanent implants,to the surgical table, or to other separate structures that are nototherwise utilized during the surgical procedure.

The preferred retractor/compression/distraction system 10 attaches toprovisionally placed pins/screws/taps 12 (“taps”), which may include thethreads 12 b, but may also be non-threaded or otherwise modified tomount to the bone segment. The taps 12 of the preferred embodiment maybe exchanged for eventual permanent screw/pin/instrument placement, suchas the pedicle screws 18. The taps 12 of the preferred embodiment may becannulated/slotted, or solid or with modifications that may allow easeof exchange for other devices or removal. The preferred taps 12 mayserve to aide in retraction and exposure or allow attachment to otherdevices, such as the preferred blades 14, that may add to retraction orexposure. The taps 12 may assist in distraction/compression/rotation ofthe bones/tissue for which they are implanted or impact other areas. Inaddition other devices may be attached to the taps 12 that assist indistraction/compression/rotation of the bones/tissues in the surgeryeither directly or indirectly. The preferred retractor/exposure system10 may be used for future placement of instrumentation or just used fordecompression, exposure and non-permanent implant purposes. Thepreferred retractor system 10 may be utilized any type of spine or bonesurgery including cervical, thoracic, lumbar, sacral, pelvic orprocedures extending across multiple segments. The preferred system 10may also be utilized from all anatomic exposure angles included and notlimited to anterior, posterior, lateral or any angle in between.

The base 16 of the preferred embodiment may be directly connected to thetaps 12 via a number of possibilities or via an intermediary such as theblade 14 that attaches from the tap 12 to the base 16. The base 16 mayfixed solely to the taps 12 or in combination to an outside stabilizingattachment, such as to a table or other mountable object.

The system 10 may be utilized to determine instrumentation sizes andcontour for screws 18 and rods 32 or other implants that are utilizedduring the surgical procedure, such as the interbody implant 30. Thetaps 12 of the preferred embodiment may be utilized to determinedefinitive instrumentation sizes and contour for the screws 18 and rods32 and other implants, including the preferred interbody implant 30.Measuring the distance between the taps 12 in the implantedconfiguration will help determine characteristics of additionalinstrumentation to be utilized. In addition the preferably provisionaltaps 12 will be able to be used with imaging technology to include butnot limited to intraoperative three-dimensional (“3D”) imaging to assistin determining characteristics of final proposedinstrumentation/implants and potentially help with improving/maintainingalignment and balancing concerns.

It will be appreciated by those skilled in the art that changes could bemade to the embodiment described above without departing from the broadinventive concept thereof. It is understood, therefore, that thisinvention is not limited to the particular embodiment disclosed, but itis intended to cover modifications within the spirit and scope of thepresent invention as defined by the present disclosure.

What is claimed is:
 1. An orthopedic kit comprising: a first tap having a first shaft with first threads and a first head, the first tap configured to form a first pilot hole in a first bone portion such that the first pilot hole is configured to receive a first bone screw; a second tap having a second shaft with second threads and a second head, the second tap configured to form a second pilot hole in a second bone portion such that the second pilot hole is configured to receive a second bone screw; a first blade having a first proximal end and a first distal end, wherein: (a) the first distal end is mountable to the first head, (b) the first blade is pivotable relative to the first head in a first mounted configuration, and (c) the first blade is configured to facilitate soft tissue retraction in the first mounted configuration to create a surgical path to a surgical site; a second blade having a second proximal end and a second distal end, wherein: (a) the second distal end is mountable to the second head, (b) the second blade is pivotable relative to the second head in a second mounted configuration, and (c) the second blade is configured to facilitate soft tissue retraction in the second mounted configuration to create the surgical path to the surgical site; a base removably mountable to the first and second proximal ends, the base being configured to manipulate the first and second blades to manipulate at least one of the first or second bone portions during a surgical procedure; wherein the first tap is not configured for permanent implantation within the first bone portion; wherein the second tap is not configured for permanent implantation within the second bone portion; wherein the first tap has a smaller outer diameter than the first bone screw; wherein the second tap has a smaller outer diameter than the second bone screw; wherein the first blade includes a first hinge and the second blade includes a second hinge; wherein the first blade includes an aperture and the aperture includes a closed monolithic eyelet; wherein (a) the first blade includes a proximal third, a middle third, and a distal third, (b) the middle third is between the proximal and distal thirds, (c) the proximal and distal thirds extend to opposing ends of the first blade, (d) the distal third includes the first hinge and the aperture, and (e) the first hinge is between the aperture and the middle third.
 2. An orthopedic kit comprising: a first tap having a first shaft with first threads and a first head, the first tap configured to form a first pilot hole in a first bone portion such that the first pilot hole is configured to receive a first bone screw; a second tap having a second shaft with second threads and a second head, the second tap configured to form a second pilot hole in a second bone portion such that the second pilot hole is configured to receive a second bone screw; a first blade having a first proximal end and a first distal end, wherein: (a) the first distal end is mountable to the first head, (b) the first blade is pivotable relative to the first head in a first mounted configuration, and (c) the first blade is configured to facilitate soft tissue retraction in the first mounted configuration to create a surgical path to a surgical site; a second blade having a second proximal end and a second distal end, wherein: (a) the second distal end is mountable to the second head, (b) the second blade is pivotable relative to the second head in a second mounted configuration, and (c) the second blade is configured to facilitate soft tissue retraction in the second mounted configuration to create the surgical path to the surgical site; a base removably mountable to the first and second proximal ends, the base being configured to manipulate the first and second blades to manipulate at least one of the first or second bones during a surgical procedure; wherein the first tap: (a) is not configured for permanent implantation within the first bone portion, and (b) has a smaller outer diameter than the first bone screw; wherein (a) the first blade includes a proximal third, a middle third, and a distal third, (b) the middle third is between the proximal and distal thirds, (c) the proximal and distal thirds extend to opposing ends of the first blade, (d) the distal third includes a hinge and an aperture, and (e) the hinge is between the aperture and the middle third; wherein (a) a portion of the distal third of the first blade includes a central axis, (b) the hinge includes a hinge axis about which the hinge rotates, and (c) the portion of the distal third of the first blade is configured to pivot about the hinge axis such that the central axis has a plurality of orientations with respect to the hinge axis and in at least one of the plurality of orientations the central axis is not parallel to the hinge axis. 